Muhammad Muddasir Khurshid

Systems / Design Engineering Leader

Senior Engineering Manager with 14+ years of experience in medical device R&D and materials engineering, I drive innovation, product excellence, and cross-functional collaboration to deliver safe, effective, and market-ready technologies.

I specialize in leading high-performing teams, managing complex projects, and solving technical challenges across systems engineering, risk management (ISO 14971), design control (ISO 13485), and biocompatibility (ISO 10993).

Selected Achievements:
• Spearheaded the development and launch of next-generation medical devices, aligning with regulatory and market needs while ensuring design efficiency and risk mitigation.
• Established a pre-clinical and clinical explant failure investigation program at Dexcom, enhancing root cause analysis capabilities and accelerating issue resolution.
• Developed patient safety and biocompatibility-driven inspection criteria, leading to a 15% yield improvement and $4.5M in annual savings.
• Directed a multi-million-dollar EU MDR materials engineering program at Medtronic, ensuring regulatory compliance across global operations.
• Led successful global remediation initiatives for Materials of Concern (e.g., REACH, RoHS, Prop 65), strengthening compliance and supply chain integrity.

Core Expertise:
• Medical Device R&D — Systems engineering, design control, V&V, product innovation
• Materials Science — Failure analysis, materials selection, biocompatibility, process optimization
• Risk Management — DFMEA, PFMEA, hazard analysis, risk control strategies
• Cross-functional Leadership — Team building, mentorship, program management
• Regulatory Compliance — ISO 13485, ISO 14971, ISO 10993, EU MDR, Materials of Concern

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